Rappel de Device Recall Superstand standup wheelchair

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par The Standing Company.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67076
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0993-2014
  • Date de mise en oeuvre de l'événement
    2013-05-16
  • Date de publication de l'événement
    2014-02-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2014-06-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Wheelchair, standup - Product Code IPL
  • Cause
    Power superstand standing wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. a newly designed flexshaft which corrects this problem is available at no charge.
  • Action
    The Standing Company sent an Urgent Medical Device Field Correction/Part Recall dated February 6, 2014, to all affected customers. The Urgent Recall notification identified the Flexshaft holding the control joystick on all Power Standing Wheelchairs were being replaced after investigation of complaints found the flexshaft could break because the inner spring of the shaft had failed, although the outer core remained intact. The notice explained how the failure would appear and that the break could happen without warning. The notice explained that the break would not cause the flexshaft to fall off the chair, or hit the ground and the chair could still be mobilized by having the user lean over and pick up the joystick. The notice warned customers not to over bend the flexshaft until replacement was performed. Consignees were asked to call 1-800-STANDING ( 1 800-782-6346) immediately if their wheelchair needed immediate flexshaft replacement. The notice stated that consignees would be contacted to set up a time and date to replace their current flexshaft, at no charge. Consignees were asked to complete and return the response form with customer contact information to Standing Wheelchair Company 5848 Dixie Hwy, Saginaw, MI 48601; Fax (989) 746-9185 or E-mail mail@thestandingcompany.com. Questions and Concerns should be addressed to Customer Service Manager Chris Moran, 1 800 782-6346. For questions regarding this recall call 989-746-9100.

Device

  • Modèle / numéro de série
    Serial No: 1306, 1313, 1342, 1349, 1362, 1358, 1359, 1392, 1391, 1406, 1402, 1407, 1426, 1441, 1451, 1018, 1453, 1399, 1523, 1477, 1480, 1482, 1497, 1494, 1505, 1516, 1533, 1537, 1536, 1535, 1542, 1544, 1549, 1543, 1550, 1562, 1563, 1566, 1580, 1572, 1573, 1574, 1571, 1578, 1583, 1641, 1593, 1591, 1592, 1599, 1604, 1600, 1615, 1616, 1614, 1622, 1631, 1637, 1643, 1635, 1640, 1634, 1648, 1666, 1652, 1657, 1663, 1664, 1676, 1689, 1665, 1683, 1691, 1688, 1701, 1703, 1711, 1698, 1712, 1719, 1728, 1731, 1726, 1740, 2165, 2172, 2175, 2177, 2257, 2182, 2197, 2205, 2258, 2259, 2262, 2270, 2283, 2279, 2281, 2298, 2306, 2310, 2312, 2330, 2334, 2503, 2515, 2328, 2514, 2523, 2525, 2550, 2561, 2568, 2581, 2573, 1684, and 1427.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, CA, DE, IA, IL , IN, KS, KY, MI, MO, NJ, OH, OK, TX, WA, WI,and WV.
  • Description du dispositif
    Superstand stand-up wheelchair || HPS-2 || A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    The Standing Company, 5848 Dixie Hwy, Saginaw MI 48601-5967
  • Société-mère du fabricant (2017)
  • Source
    USFDA